U.S. medical agency conducting internal investigation

Below:

WASHINGTON — A boss sends a red bra to a former female subordinate who had a falling out with him. Government e-mails distribute profanity and a picture of a partly nude woman. An order to better protect patients in a medical experiment takes two years to complete.

Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

All of that happened inside the National Institutes of Health, the nation’s premier medical research agency, according to sworn testimony and other documents obtained by The Associated Press from a variety of sources inside and outside the NIH.

Two senior female officers testified that the NIH workplace is so uncomfortable and intimidating that safety concerns are frequently dismissed and some employees are afraid to speak up.

“It can be fairly uncomfortable,” NIH medical officer Betsy Smith said in a recent civil-case deposition that has been turned over to federal and Senate investigators. “There are a number of things that you really don’t talk about.”

In such a work environment, “You don’t hold up any projects even if you feel there are safety issues for certain projects,” she said.

Documents tell of women being hugged or kissed by bosses, or being subjected to catcalls in the hallway. In one instance, a supervisor invited a colleague to a West Coast rock concert and suggested they also visit an AIDS clinic there so the trip could be charged to taxpayers.

Smith and the top regulatory compliance officer in the NIH’s AIDS division, Mary Anne Luzar, stepped forward in interviews with investigators and in sworn depositions in recent weeks and expanded upon allegations made last year by an agency whistleblower, Dr. Jonathan Fishbein. Their videotaped testimony was given in Fishbein’s lawsuit against the agency.

Unwanted hugs, catcallsFishbein alleges he is in the process of being fired as the AIDS division’s chief of human research protection because he raised concerns about patient safety and shoddy science. NIH says he was fired for poor performance.

The Senate and the inspector general at the Health and Human Services Department are investigating the allegations. In addition, officials told the AP that NIH is conducting an internal investigation on sexual harassment.

NIH managers acknowledged in interviews that there are problems in their AIDS research program, which pays hundreds of millions of dollars for experiments across the globe. They said they could not address specific allegations because of the investigations, but were taking steps to end any sexual harassment and improve communication among employees when safety issues arise.

“We must be sure our staff works productively and in a timely fashion with our investigators to resolve any issues related to the conduct of our studies, with the highest priority paid to patient safety,” said Dr. H. Clifford Lane. He is deputy director of the National Institute of Allergy and Infectious Diseases, which oversees the AIDS research division.

Lane said “sexual harassment is not tolerated at NIH and we are committed to ensuring that all employees are treated with dignity and respect.”

The two new witnesses testified in recent weeks to actions they alleged made the workplace intimidating. Examples included:

Luzar, the AIDS division’s compliance officer, alleged that her bosses frequently sided with the front-line researchers they are financing, rather than with the agency’s safety and regulatory experts.

“I think we (safety officials) got in the way, and that we were an impediment to the science,” Luzar testified. She described the division managers as “totally unsupportive” of safety concerns and bending to “tremendous pressure” from drug companies and researchers in the name of trying to cure AIDS.

“I think the culture was certainly strong for a period of time that the ends could justify the means,” she testified.

'Scientific terrorism'Smith said Fishbein was a strong advocate for improving safety for research participants and the effort to fire him is “a warning to other individuals.”

After Fishbein was forced out, she said, NIH held a meeting at which he and his allegations were attacked and a picture of one of Fishbein’s relatives was shown on a screen. Smith said the event was so intimidating that fellow safety and medical officers “called it scientific terrorism.”

Documents obtained by the AP show that nearly a year ago, NIH managers were warned by the agency’s civil rights protection office in a letter that the deputy director of the AIDS division, Dr. Jonathan Kagan, had sent numerous e-mails containing “profanity and sexual innuendo” and “unprofessional and inappropriate statements.”

The letter included e-mails showing Kagan sent to a male worker a picture of a bare-breasted woman with the caption “priceless” and sent a note jokingly instructing an employee to leave his pager behind and bring “bongs,” or drug paraphernalia, to an event. Kagan also used profane language in a variety of communications, the e-mails show.

NIH officials acknowledged they took no action after getting the letter last May. The investigation remains open, they said.

Luzar, who had disagreements with Kagan over her performance, testified that Kagan once hugged her inappropriately upon hearing her father had died, and routinely kept a mug on his desk with a phrase that included a four-letter expletive.

“I found it very intimidating to walk into Dr. Kagan’s office for a one-on-one and see this — the first, first thing you see on the left side as you walk in the door is the cup,” Luzar testified.

Alyza Lewin, Kagan’s lawyer, said her client occasionally hugged or kissed female subordinates, and used “earthy language” in some e-mails to workers. Lewin also said Kagan once had retrieved a red bra that had been a gag gift among women in the office and sent it to a woman who had been a subordinate and who had transferred from his office after a falling out with him.

'Sexual games. Sexual taunting.'Lewin said the NIH’s ombudsman talked with Kagan about the bra incident but her client was never disciplined for any sexual harassment and never intended to offend women. She said the mug was bought from a popular Web news site and that he removed it from his desk once learning it bothered people.

“Dr. Kagan never sexually harassed any NIH employee,” his lawyer said. “It is noteworthy these allegations were not raised at the time the incidents allegedly occurred, but only now in connection with Dr. Fishbein’s employment action.”

Smith, the medical officer, testified that supervisors elsewhere inside the NIH behaved similarly. She recounted how one colleague had difficulty breaking off a sexual relationship with a branch chief and said that when others at the agency went on trips, they learned “the hotel only has one room so that the female scientist has to stay with her superior.”

“I’m specifically describing individuals that don’t appear to be able to interact with females without having some amount of sexuality implied,” Smith testified. “Some sexual games. Sexual taunting. Sexual innuendo going on.”

Investigators from the Senate Finance Committee who interviewed some NIH employees have obtained documents showings that safety concerns about AIDS studies were frequently overruled or delayed by supervisors.

Luzar testified that NIH failed for two years to comply with federal regulations and her demand — first made in April 2003 — to update the safety protocol and instruct researchers in the field to consider new warnings to patients in a $36 million AIDS drug trial after new side effects emerged, including suicidal tendencies.

The NIH acknowledged the delay, but said patients were never in jeopardy because doctors were told about side effects as they became known.

“It is clear we can do a better job in our communications within the division and our communications with our investigators,” said Lane, the NIH’s No. 2 infectious disease official. “We want to see all our processes take place in the quickest possible way, and two years is long time for any process.”

—Smith detailed how a NIH supervisor delayed reporting for days the death of a patient in an experiment. The supervisor was “behaving as if she were a pharmaceutical company and did not clearly understand regulatory requirements for such a study,” Smith testified.